Senior Executive - Technology Transfer (OSD Formulation)

Rubicon Research; Mumbai, Ambernath; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Rubicon Research in Mumbai seeks a seasoned Technology Transfer professional to lead scale-up, tech transfers and batch execution for Oral Solid Dosage products. You will own documentation lifecycles including BMRs, BPRs, MFC reviews, and CAPA-driven improvements, while ensuring QMS and regulatory alignment across USFDA/MHRA audits.

You will work cross-functionally with R&D, Production, QA, and Regulatory Affairs to resolve technical bottlenecks and drive robust process validation, hold-time,

Qualifications

• Mastery of technology transfer lifecycle from R&D to commercial scale.
• Proficiency in compiling regulatory-grade BMRs, BPRs, and CVP/validation docs.
• Ability to design and execute process validation and hold-time studies.

Responsibilities

• Plan, coordinate, and lead scale-up, pilot, optimization, and commercial exhibit batches for OSD products.
• Author/review Batch Manufacturing Records and Batch Packing Records for comprehensive documentation.
• Develop and execute process validation protocols and reports with regulatory rationale.
• Draft and evaluate Hold Time Study protocols for in-process materials.
• Review Master Formulation Card to align R&D designs with production scale.
• Investigate and resolve shop floor processing issues through troubleshooting.
• Manage QMS records for Technology Transfer, including Change Controls, Deviations, and CAPA.
• Collaborate with R&D, Production, QA, and Regulatory Affairs to resolve quality events and milestones.
• Support new manufacturing technologies and high-end processing equipment.
• Conduct QRM assessments for existing and new workflows.
• Maintain readiness of Tech Transfer docs for USFDA, MHRA, and global audits.
• Perform site trials, docs updates, and provide technical support to senior leadership.

Skills

Scale-Up & Batch Execution

Technical Documentation

Process Troubleshooting

QMS Frameworks

Cross-Functional Communication

Education

B.Pharm / M.Pharm

Job description

Role & responsibilities

To lead the scientific scale-up, technology transfer, and execution of exhibit batches for Oral Solid Dosage (OSD) formulations at the manufacturing unit. This role takes full technical ownership of documentation lifecycle frameworks including BMRs, validation protocols, and Master Formulation Cards while driving process troubleshooting and robust QMS compliance under the MSAT division.

Responsibilities

• Plan, coordinate, and lead the flawless shop-floor execution of scale-up, pilot, optimization, and commercial exhibit batches for OSD products.
• Author, review, and compile critical technical documentation including Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
• Design and execute comprehensive Process Validation protocols and reports based on sound scientific and regulatory rationales.
• Draft, execute, and evaluate complex Hold Time Study protocols and reports for in-process bulk materials.
• Conduct detailed reviews of the Master Formulation Card (MFC) to ensure seamless alignment between R&D designs and commercial production scale.
• Identify, investigate, and resolve shop floor processing anomalies and technical bottlenecks through active process troubleshooting.
• Handle the end-to-end lifecycle of QMS records related to Technology Transfer, including Change Controls, Deviations, and CAPA implementation.
• Collaborate cross-functionally with R&D, Production, Quality Assurance, and Regulatory Affairs to resolve quality events and clear tech transfer milestones.
• Support the implementation of new manufacturing technologies and high-end processing equipment to enhance facility outputs.
• Conduct Quality Risk Management (QRM) assessments and risk reviews for existing and newly transferred manufacturing workflows.
• Keep the Technology Transfer documentation infrastructure in a perpetual state of readiness for USFDA, MHRA, and global regulatory audits.
• Perform tactical production trials, documentation updates, and site technical support tasks assigned by senior leadership.

Required Skills

• Scale-Up & Batch Execution: Masterful command over the technology transfer lifecycle, pilot-to-commercial scale-up protocols, and commercial exhibit batch execution.
• Technical Documentation: Prolific technical writing capabilities to compile regulatory-grade BMRs, BPRs, process validation protocols, and hold-time reports.
• Process Troubleshooting: Advanced technical acumen to diagnose, isolate, and resolve physical manufacturing defects (e.g., blend uniformity issues, capping, sticking).
• QMS Frameworks: Strong capability to manage complex QMS documentation, author investigation rationales, and design sustainable engineering CAPAs.
• Cross-Functional Communication: Exceptional written and verbal communication skills required to align R&D tech transfers with commercial plant realities.

Preferred Candidate Details

• Education: Full-time B.Pharm / M.Pharm degree from a recognized university.
• Experience Range: 10 to 12 years of core experience strictly focused on Technology Transfer / MSAT inside an OSD manufacturing setup.
• Dosage Form Focus: Deep hands-on process knowledge handling complex Solid Oral (OSD) matrices (tablets, capsules, bilayer compression, film coating).
• Regulatory Exposure: Proven history of facing and defending technology transfer portfolios during USFDA / MHRA regulatory inspections.
• Operational Drive: A self-driven, detail-oriented engineering professional ready to work flexibly across rotational shifts to support continuous batch trials.